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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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GalaFLEX 3DR - 00810054980063

GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100043-07
Not in Commercial Distribution

  • 00810054980063 ()

  • Height: 7.6 Centimeter
  • Length: 20.3 Centimeter
FR3D07

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980056

GalaFLEX 3DR Scaffold, 7.5 cm x 21.0 cm, Large Oval (Contents: 2)
Tepha, Inc.
100043-06
In Commercial Distribution

  • 00810054980056 ()

  • Length: 21 Centimeter
  • Height: 7.5 Centimeter
FR3D06

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980049

GalaFLEX 3DR Scaffold, 7.5 cm x 21.0 cm, Large Oval (Contents: 1)
Tepha, Inc.
100043-05
In Commercial Distribution

  • 00810054980049 ()

  • Height: 7.5 Centimeter
  • Length: 21 Centimeter
FR3D05

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980032

GalaFLEX 3DR Scaffold, 6.4 cm x 18.5 cm, Medium Oval (Contents: 2)
Tepha, Inc.
100043-04
In Commercial Distribution

  • 00810054980032 ()

  • Length: 18.5 Centimeter
  • Height: 6.4 Centimeter
FR3D04

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980025

GalaFLEX 3DR Scaffold, 6.4 cm x 18.5 cm, Medium Oval (Contents: 1)
Tepha, Inc.
100043-03
In Commercial Distribution

  • 00810054980025 ()

  • Height: 6.4 Centimeter
  • Length: 18.5 Centimeter
FR3D03

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980018

GalaFLEX 3DR Scaffold, 5.3 cm x 15.5 cm, Small Oval (Contents: 2)
Tepha, Inc.
100043-02
In Commercial Distribution

  • 00810054980018 ()

  • Length: 15.5 Centimeter
  • Height: 5.3 Centimeter
FR3D02

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980001

GalaFLEX 3DR Scaffold, 5.3 cm x 15.5 cm, Small Oval (Contents: 1)
Tepha, Inc.
100043-01
In Commercial Distribution

  • 00810054980001 ()

  • Height: 5.3 Centimeter
  • Length: 15.5 Centimeter
FR3D01

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

EchoMark - B53630001

EchoMark is an implantable ultrasound surgical site marker for soft tissue. The marker is comprised of a bioresorbable polymer.
SONAVEX, INC.
3000
In Commercial Distribution

  • B53630001 ()

  • Large


  • Radiological image marker, implantable

EchoMark LP - B53620001

EchoMark LP is an implantable ultrasound surgical site marker for soft tissue. The marker is comprised of a bioresorbable polymer.
SONAVEX, INC.
2000
In Commercial Distribution

  • B53620001 ()

  • Small


  • Radiological image marker, implantable

ARAMBURO / WOOD LAP COLE - 30607915136575

Kit Contains: CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CTF12, 5x100 Kii® Fios® ZTHR DP 10/BX C0Q20, 5x100 Kii® BALLOON BLUNT TIP 6/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2864
In Commercial Distribution

  • 30607915136575 ()


  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
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